The present invention relates to an apparatus for ligating/suturing living tissues and a system for resecting/suturing living tissues, for carrying out endoscopic repair such as resecting/suturing or ligating or suturing living tissues in the patient's body in combination with an endoscope. More particularly, the present invention relates to a repair system for carrying out the following repairs in a digestive tract including:                suturing for repair of a damaged site of tissues or reliable hemostasis of a bleeding part;        forming an artificial valve depending on tissues for Gastroesphageal Reflux Disease (GERD); and        resecting a lesion that exists in an organ wall such as mucous membrane having a surface existing lesion part or sub-mucous tumor.        
Currently, in the case of carrying out repair of a diseased site of living tissues in a patient's body, suturing for the purpose of reliable hemostatis of a bleeding part, these repairs and anastomosis are generally carried out by surgical operation.
However, in the case of surgical operation, of course, it is required to dissect the patient's body, and patient invasion is significant. In addition, postoperative hospitalization is required, and a burden on the patient on the aspect of cost such as hospitalization cost is significant. In such a circumstance, it is desirable to establish repair using lowly invasive peroral endoscope in which there is no need to dissect the patient's body.
In addition, the Gastroesophaseal Reflux Disease (GERD) is one of the diseases whose number of patients is likely to increase. Main diseases include heartburn and esophageal mucosal break. Although it is a benign disease, the patient's pain is significant. Thus, this disease is characterized in that a very large number of patients who require repair. This disease is primarily caused by degradation of a function of Lower Esophageal Sphincter (LES) that exists at the esophageal lower part and gastric acid reflux into an esophagus.
In the repair of the GERD, administration of gastric secretion inhibitor such as proton-pump inhibitors or the like is primarily carried out. If the GERD is light, the diseases is improved, and the radical cure of the cause of this disease can be expected. However, a repair effect with medication is small in a case where the function of the LES is significantly degraded, or alternatively, in a case of severe diseases with anatomic problems such as Hiatal Hernia. In addition, there is a problem that higher cost is indispensable because continuous administration is required. Therefore, in the severe GERD, surgical operation is applied.
As effective operation techniques, Nissen fundoplication and Toupet techniques or the like are widely carried out. In any of these techniques, the LES part is wrapped at a gastric wall, whereby functional improvement of the LES is carried out, and high repair effect is attained. Recently, laparoscopic technique is established, thus enabling more lowly invasive repair.
However, because the number of patients is very large and the above disease is a benign disease unlike cancers, it is desirable to establish a repairing technique using a much lower invasive and peroral endoscope. As one of such operation techniques, there is designed a method of ligating living tissues and inflating the tissues, and forming an artificial valve, thereby preventing reflow of gastric acid.
In addition, there is known a method of resecting a mucous membrane or sub-mucous tumor in a body cavity in a peroral and endoscopic manner. In this method, a high frequency resecting device and a grasping forceps are used in combination with an endoscope. Then, a liquid such as physiological saline is locally charged into a sub-mucous layer, and then, living tissues are pulled by the grasping forceps. Subsequently, the pulled up living tissues are resected by the high frequency resecting device in accordance with a predetermined procedure.
There is a possibility that bleeding occurs at a part at which a mucous membrane or sub-mucous layer is resected immediately after resection, or alternatively, after an elapse of time after operation. Thus, currently, a resected portion is clipped by using an endoscopic clipping device or the like after resection, whereby preventive hemostasis is carried out.
In addition, if the resected portion is kept as is, an ulcer or the like occurs. Because of this, the following method is used in order to prevent the occurrence of such an ulcer or the like or repair it at an earlier stage. Here, the peripheral mucous membrane of the resected portion is pulled onto the resected portion, and the pulled part is fixed by using the clipping device so as to protect the resected portion.
However, where the mucous membrane, sub-mucous layer or the like is resected in a wide range, it is required to carry out a plurality of clipping manipulations. Because of this, there is a problem that the operation technique is very complicated, and the treatment time is extended. Moreover, in this treatment, it is required to replace a high frequency treatment device or grasping forceps and a clipping device with an endoscope channel. In this respect as well, the operation technique is complicated, and the treatment time is extended.
Thus, it is desirable to develop a method of resecting living tissues, thereby making it possible to easily suturing the resected site. As a device for suturing living tissues in a patient's body in a peroral, endoscopic manner, for example, there is proposed a device “a” (refer to FIG. 46A to FIG. 47B) that can be mounted on an endoscope as disclosed in U.S. Pat. No. 5,792,153.
As shown in FIG. 46A, a suction cavity “c” is provided at a distal end section of this device “a”. A tube “b” is inserted into this cavity “c”. This tube “b” can be connected to a suction source.
Further, a hollow needle “d” inserted into the endoscope's forceps channel is provided at the device “a”. A pipe shaped thread carrier “g” can be mounted in this needle “d”. This thread carrier “g” has an internal cavity and side holes “e” and “f”. A wire “i” is retractably inserted into the needle “d”. A valve “h” is provided at the wire “i”. This valve “h” can be removably engaged with the side hole “e” of the thread carrier “g”.
In addition, a thread “j” is connected to the thread carrier “g”. A trapping member “k” is provided at a distal end side of the cavity “c”. This trapping member “k” is removably engaged with the side hole “f” of the thread carrier “g”.
When this device “a” is used, the thread carrier “g” is mounted in the needle “d” while the valve “h” is engaged with the side hole “e” in advance.
Next, the endoscope having the device “a” mounted thereon is inserted into the patient's body in a peroral manner. After the endoscope has been inserted, living tissue “m1” to be sutured as shown in FIG. 46A is suctioned into the cavity “c”.
Then, the needle “d” is pushed out from the endoscope, and the living tissue “m1” is punctured by this needle “d”, as shown in FIG. 46B.
Next, the wire “i” is advanced, and the thread carrier “g” is pressed forwardly from the needle “d”. Then, the side hole “f” of the thread carrier “g” and the trapping member “k” are engaged with each other.
Then, the valve “h” is removed from the side hole “e”. In this state, as shown in FIG. 46C, the wire “i” and the needle “d” are retracted into the endoscope. At this time, the thread “j” of the thread carrier “g” is sutured around the living tissue “m1”. Subsequently, suction of the cavity “c” is released. In this manner, the living tissue “m1” slips off from the cavity “c”. Then, a first manipulation for suturing the thread “j” of the thread carrier “g” around the living tissue “m1” terminates.
Next, another part (living tissue “m2”) of the living tissue “m1” is suctioned into the cavity “c” again. In this state, as shown in FIG. 47A, the living tissue m2 is punctured by the needle “d”.
Subsequently, the wire “i” is advanced, thereby causing the valve “h” to be engaged with the side hole “e”. Then, the trapping member “k” is released from the side hole “f”. In this state, the valve “h”, the thread carrier “g”, and the needle “d” are retracted to the proximal end side. At this time, the thread “j” is sutured around the living tissue “m2”. Subsequently, suction of the cavity “c” is released. In this manner, as shown in FIG. 47B, the living tissue “m2” slips off from the cavity “c”. Then, a second manipulation for suturing the thread “j” around the living tissue “m2” terminates.
Further, the above step of suturing the thread “j” around the living tissue “m” is repeated in its required number. Then, after a work of suturing the thread “j” around the living tissue “m” in its required number has terminated, the device “a” is removed from the inside of the body to the outside together with the endoscope. Finally, both ends of the thread “j” pulled out to the outside of the body are knotted and fixed, thereby terminating suturing.
However, the following problem occur in the case of the device “a” having its constitution disclosed in U.S. Pat. No. 5,792,153. That is, after the thread “j” has punctured into the living tissue “m”, means for ligating the thread “j” is not provided at the device “a” itself. Thus, a work of knotting both ends of the thread “j” at the outside of the patient's body, and then, delivering the knot into the patient's body is required. As a result, the operation technique of suturing the living tissues in the patient's body is complicated, and the treatment time is extended as well.
In addition, in the case of carrying out a plurality of stitch manipulations as well, a distance between stitches cannot be controlled reliably. Thus, it is difficult to reliably carry out suturing in a small number of stitch manipulations.
Two manipulations, i.e., one engaging manipulation between the valve “h” and the side hole “e” or between the trapping member “k” and the side hole “f” and the other disengaging manipulation are required every time the needle “d” is operated to be punctured. Thus, manipulation of the device “a” is very complicated, and the treatment time is extended.
In addition, the range that can be punctured in one puncturing manipulation of the needle “d” is determined depending on the size of the cavity “c”. However, considering a burden on the patient when the device “a” is inserted into the patient's body, the external diameter of the entire device “a” is dimensionally limited itself, and the external diameter of the entire device “a” is not increased dimensionally. Then, in this constitution, the endoscope and the cavity “c” are disposed at their displaced position. Thus, there is a problem that the size of the cavity “c” is reduced. In the case where the suture range of the living tissue “m” is wider than that when absorbed into the cavity “c” by suction, its suturing is impossible, and its application is limited.
In addition, in International Patent Application Publication WO99/22649, there is disclosed a device “n” for forming inflation of the living tissues in order to repair the peroral gastroesophageal reflux disease (refer to FIG. 48 to FIG. 49D).
This device “n” has a movable arm “p” that is turnable at a distal end of a flexible tube “o”. Further, a female fastener “r” is selectively mounted on the movable arm “p”, and a male fastener “q” is selectively mounted on the flexible tube “o” that can be connected when this movable arm “p” is turned, respectively.
Similarly, turnable grip means “s” and an endoscope insertion opening “u” are provided at a distal end of the flexible tube “o”. An endoscope “t” can be inserted into the opening “u” of this flexible tube “o”. This endoscope “t” is inserted over the full length of the flexible tube “o”.
Then, the following manipulation is carried out when this device “n” is used. First, as shown in FIG. 49A, the flexible tube “o” is inserted into the patient's stomach in a peroral manner. Subsequently, the grip means “s” is abutted against an esophagogastric junction “v”.
At this time, the grip means “s” is manipulated, and the esophagogastric junction “v” is gripped as shown in FIG. 49B. Subsequently, the flexible tube “o” is advanced to the anal side, and the esophagogastric junction “v” is pulled down.
Here, as shown in FIG. 49C, the movable arm “p” is manipulated to be turned. At this time, as shown in FIG. 49D, the esophagogastric junction “v” gripped by the grip means “s” is punctured through the male fastener “q”, and is engaged with the female fastener “r” as is.
The esophagogastric junction “v” gripped by the above manipulation is reduced in length, its intermediate portion is reduced and pushed out inwardly, and a rise “x” is formed. At this time, in the device “n” of the above International Patent Application Publication WO99/22649, a positional relationship between the grip means “s” and the male fastener “q” or female fastener “e” is fixed. Thus, the size of the rise “x” is uniquely determined.
In general, in surgical operation (Nissen fundoplication), a food passing problem (disphagia) is reported as a complication of artificial cardia. In this operation technique for repair of gastroesophageal reflux disease as well, there is a danger that a similar problem occurs with a large rise “x”. Therefore, in the case of a light disease, the degree of the rise “x” is reduced, whereby it is preferable that priority be assigned to food passing. In this way, in the repair of a gastroesophageal reflux disease, it is advantageous that the rises “x” of various sizes can be formed according to the degree of the diseases.
However, in the device “n” of the above International Patent Application Publication WO99/22649, the size of the rise “x” is uniquely determined, thus making it difficult to have flexibility in the course of repairing the gastroesophageal reflux disease.
In addition, the female fastener “q” is exposed to the external surface of the device, and thus, there is a possibility that the female fastener “q” comes into contact with the body wall when this device is inserted into the body cavity.